MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (7l43651), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by sales rep that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the suture had so much resistance while sliding the suture to tie a knot that the suture bridge/cross bar broke causing all the sutures to become unloaded from the anchor on the 4.5 healix advance peek 3-suture anchor w/ orthocord device.This is report 1 of x for (b)(4).Another like device was used to complete the procedure with a delay of less than 30 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14830205
• Report Number: 1221934-2022-01878
• Device Sequence Number: 2351114
• Product Code: HWC
• UDI-Device Identifier: 10886705021406
• UDI-Public: 10886705021406
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 222304
• Device Catalogue Number: 222304
• Device Lot Number: 7L43651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown